It is believed that chronic prostatitis is one of the most common reasons why men visit urologists, even being characterized as the condition responsible for more outpatient visits than benign prostatic hyperplasia (“BPH”) or prostate cancer. At least one report states that 35-50% of men will be affected by prostatitis at some time in their life. The treatments conventionally used to treat this condition have been generally problematic; most of the treatments have provided little hope that the condition could be predictably treated in a manner which could successfully alleviate the pain experienced by a large percentage of these individuals. Indeed, prostatitis has been termed “a waste basket of clinical ignorance” because of the lack of knowledge about the basic epidemiology of the disease and also the diagnosis and treatments available for the same. See Collins et al., J. Urology, 159: 1224-1228, 1998.
Unlike BPH, which occurs primarily in older men, prostatitis can occur in both younger (men in age groups of 18-50) and older men (over the age of 50), with the median reported patient age at about 40 years of age. It is thought to be the most common urologic diagnosis for men less than 50 years of age.
There are several classifications or types of prostatitis, each of which may have different characteristics, manifestations, symptoms, or treatment protocols. Type I is acute bacterial prostatitis; Type II is chronic bacterial prostatitis; Type III is chronic (non-bacterial) prostatitis and/or chronic pelvic pain syndrome (CPPS); and Type IV is asymptomatic inflammatory prostatitis. See Nickel et al., Urology, 54(2): 229-233, 1999. Type III prostatitis (non-bacterial chronic prostatitis) is generally associated with urogenital pain in the absence of uropathogenic bacteria detected by standard microbiological methodology. Id. Type III prostatitis can be further defined as IIIA (inflammatory) or IIIB (noninflammatory). The IIIA inflammatory type prostatitis can be identified based on the presence of leukocytes in expressed prostatic secretions or fluids, post prostatic massage urine, or semen, while the IIIB non-inflammatory type can be identified based on the absence of detectable leukocytes in similar specimens. This type of prostatitis may also be associated with variable voiding, sexual dysfunction, and/or psychologic alterations (particularly depression).
Only a small number of reported prostatitis cases are believed to be of the Type I or acute bacterial type, while the remaining classes of chronic prostatitis may affect an estimated 30 million men in the United States. As such, chronic prostatitis is a major health care issue.
To assess the severity of prostatitis symptoms and responsiveness to certain therapies, certain standardized assessment protocols can be used. For example, the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) was nominated as the standard of choice for clinical trials occurring after 1999. Similarly, other scores, indexes and surveys can be used to diagnose or assess treatment efficacy, such as an International Prostate Symptom Score (IPSS) system of seven questions.
Various treatment protocols have been used to attempt to treat prostatitis. While Type I and II may be managed successfully with specific antibiotics that penetrate the prostate, patients having Type III prostatitis have had lesser degrees of response success when treated with antibiotics. Other treatment regimes include other drugs such as alpha-blocker therapy (for obstructive voiding), and anti-inflammatory agents. In addition, or alternatively, the physician may suggest lifestyle changes such as diet (such as the reduction of the intake of caffeine), exercise, sexual activity, and/or supportive psychotherapy.
Additional treatment protocols suggested include repetitive prostate massage via the rectum as performed by the patient or assisted by another (such as 2-3 times per week), phytotherapy, transurethral microwave thermo (heat) therapy, or even radical transurethral resection of the prostate, radical open prostatectomy, and bladder neck surgery. Unfortunately, these prostatitis treatments result in a dismal cure rate and an unacceptably high relapse or recurrence rate.
In view of the above, there remains a need to provide improved and/or alternative treatments for chronic prostatitis.